(107 days)
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components may provide functions for performing related to image manipulation, enhancement, compression or quantification. And images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components may provide functions for performing related to image manipulation, enhancement, compression or quantification.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for a medical device study.
The document is an FDA 510(k) clearance letter for a device named "QXLink". It states that the device is substantially equivalent to a legally marketed predicate device. The letter primarily addresses regulatory compliance and provides indications for use for the QXLink device, which is a Picture Archiving and Communications System (PACS).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the given information.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).